Hypoglycemia is by definition an abnormally low blood sugar level and may be induced by an overdose of exogenous insulin and certain synthetically produced drugs. Well known hypoglycemic drugs are the sulfonylureas, e.g. tolbutamide, chlopropamide, acetohexamide, and tolazamide, which are related chemically to the sulfonamides, and the guanidine derivatives, e.g. phenformin. All of the sulfonylureas act in a similar manner, i.e. by stimulating pancreatic insulin release and decreasing the glucose output from the liver. While the mechanism of action of phenformin is unknown, it is known that the compound inhibits mitochondrial respiratory enzyme systems. It is believed that the inhibition of that enzyme system accelerates glycolysis bringing about hypoglycemia by increasing glucose uptake by the peripheral tissues and decreasing hepatic gluconeogenesis.
While the discovery that such synthetically, produced chemicals were effective in reducing blood sugar levels and represent an advance in the art in the treatment of mild diabetes, such drugs have several disadvantages in therapeutic use, not the least of which is the increased risk of acute cardiovascular distresses and even death brought about by their use. In any event, physiologically, the known hypoglycemic drugs are not effective in treating diabetic acidosis or in stressful situations such as infection and surgical procedures.
The product of the invention has the potential of overcoming the disadvantages of the synthetically produced hypoglycemic agents by virtue of the fact that the inventive agent is naturally occurring. Moreover, it may be appreciated that cockleburrs commonly occur in all parts of the world and as such provide a relatively inexpensive source of raw material for world wide production of a naturally occurring insulin substitute. One of the principle advantages of the invention is that the product does not produce its results by causing production of insulin by stimulation of the Islets of Langerhans in the pancreas which mechanism of activity has heretofore limited the use of synthetic drugs to the mildest of diabetic conditions.